EUCTR2014-000202-35-FR
Active, not recruiting
Phase 1
Prevention of early ventilator-associated pneumonia with antibiotic therapy in patients treated with mild therapeutic hypothermia after cardiac arrest. Randomized, multicenter double-blind placebo-controlled trial. - ANTHARTIC
CHU de LIMOGES0 sites194 target enrollmentJune 22, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CHU de LIMOGES
- Enrollment
- 194
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Patients older than 18 years\-old, mechanically ventilated after an out\-of\-hospital resuscitated cardiac arrest secondary to shockable rhythm
- •\-Hospitalized in an ICU
- •\-Mild therapeutic hypothermia procedure scheduled (24 to 36 hours) before randomization
- •\-Delay from ROSC to randomisation \< 6 hours
- •\-Consent from family members or emergency consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 92
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •\-Pregnant women
- •\-Out\-of\-hospital cardiac arrest secondary to non shockable rhythm (mild therapeutic hypothermia not yet evidence based”)
- •\-In\-hospital cardiac arrest
- •\-Need for cardiac support by cardiopulmonary bypass
- •\-Ongoing antibiotic therapy or during the week before
- •\-Ongoing or concomitant pneumonia
- •\-Known chronic colonization with MRB
- •\-Known severe allergy to beta\-lactame antibiotics (Quincke edema, shock) and amoxicillin\-clavulanic acid use contraindications
- •\-Previous lung disease making radiological interpretation difficult for VAP diagnosis
- •\-Predictable decision of early care limitation or withdrawal (\< 7 days)
Outcomes
Primary Outcomes
Not specified
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